Laboratories use a variety of laboratory management systems to integrate laboratory software and instruments; to manage samples, laboratory users, and standards; to control other laboratory functions such as Quality Assurance (QA) and Quality Control (QC); to conduct sample planning, invoicing, and plate management; and to manage workflow. Laboratory management systems can include a variety of different types of systems for managing samples, information and/or instruments within a laboratory, such as a Laboratory Information System (LIS), a Process Development Execution System (PDES), and a Laboratory Information Management System or Laboratory Integration Management Solution (LIMS).
A Laboratory Information System (“LIS”) is a class of software that receives, processes, and stores information generated by medical laboratory processes. LIS systems often must interface with instruments and other information systems such as hospital information systems (HIS).
A Process Development Execution System (PDES) is a system which is used by companies to perform development activities for manufacturing processes.
A Laboratory Information Management System or Laboratory Integration Management Solution (LIMS) is a software system used in laboratories for the integration of laboratory software and instruments and the management of samples, laboratory users, standards and other laboratory functions such as Quality Assurance (QA) and Quality Control (QC), sample planning, invoicing, plate management, and workflow automation. LIMS systems may also support information gathering, decision making, calculation, review and release into the workplace and away from the office. More recently, LIMS systems are starting to expand into Electronic Laboratory Notebooks, assay data management, data mining and data analysis.
Modern laboratory management systems have implemented extensive configurability as each laboratories needs for tracking additional data points can vary widely. Vendors of laboratory management systems often cannot make assumptions about what these data tracking needs are and therefore need to be adaptable to each environment. Users of laboratory management systems may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP and FDA specifications and this can affect certain aspects of sample management in a laboratory management system. One key to compliance with many of these standards is audit logging of all changes to data of laboratory management systems, and in some cases a full electronic signature system is required for rigorous tracking of field level changes to data of laboratory management systems.
A user may configure a laboratory management system whereby users are assigned roles or groups. Typically the role of a user will dictate their access to specific data records in the laboratory management systems. Each user account is protected by security mechanisms such as a user id and a password. Users may have customized interfaces based on their role in the organization. For example, a laboratory manager might have full access to all of a laboratory management system's functions and data, whereas technicians might have access only to data and functionality needed for their individual work-tasks.
Some laboratory management systems offer some capability for integration with instruments. A laboratory management system may create control files that are “fed” into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The laboratory management system may then import instrument results files to extract QC or results data for assessment of the operation on the sample or samples. Data owners may access the resulting stored information at any time.
Laboratory management systems may be customized for use in a wide variety of settings and laboratories, such as medical or clinical laboratories, biological laboratories, chemistry laboratories, chemical or petroleum laboratories, commercial or manufacturing use, forensics or crime laboratories, pathology laboratories, public safety and public health laboratories, and water processing and testing facilities.
Laboratory management system may manage various workflows within a laboratory, such as the management of samples within a laboratory, the management of information within a laboratory, and the management of instruments within a laboratory. Samples include: biological samples taken from a patient, such as blood, urine or tissue; evidence samples taken from a crime scene, such as bullets, biological samples, pictures, and video; and samples of materials, liquids, or compounds. Instruments includes analyses equipment within a laboratory and any other laboratory equipment, measurement instruments, observation instruments such as a microscope or a video camera, sensors and other such equipment within a laboratory.
One core function of laboratory management systems is the management of samples. This typically is initiated when a sample is received in the laboratory at which point the sample will be registered in the laboratory management system. This registration process may involve accessioning the sample and producing barcodes to affix to the sample container. Various other parameters may be recorded as well, such as clinical or phenotypic information corresponding with the sample. The laboratory management system may then track chain of custody of the sample as well as the sample location. Location tracking often involves assigning the sample to a particular location such as a shelf/rack/box/row/column. Other event tracking may be required such as freeze and thaw cycles that a sample undergoes in the laboratory.
In order manage a workflow in a laboratory management system, a user typically has to write program code for a computer program through which the rule operates for each rule for which the user wishes to create. The task of writing program code for a rule is often laborious and requires many hours of work from a trained computer programmer to complete. Writing program code for a rule also requires an in-depth understanding of how the laboratory management system functions. Typically, the user of a laboratory management system does not have the type of training and skills needed to write the program code needed from which the rule operates. Thus the task of writing program code for a rule usually falls to a software engineer.
It would be desirable to provide a simplified method for developing rules for managing a workflow in a laboratory management system which do not require the use of a software engineer. It would also be desirable to provide a simplified method for developing rules for managing a workflow in a laboratory management system from which an end-user could develop program code for.